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In dentistry, dental implant applications for tooth loss/deficiency are prominent and provide successful long-term results in terms of functionality and aesthetics. However, peri-implant diseases such as peri-implant mucositis and peri-implantitis may develop due to biofilm accumulation around the implant. In peri-implantitis, in addition to the clinical inflammation findings seen in peri-implant mucositis, there is also progressive bone loss. This condition is to be treated with non-surgical or surgical methods. Titanium curettes, ultrasonic instruments, laser systems, and chitosan brushes are used for biofilm removal in non-surgical treatment. Chitosan is a natural polysaccharide obtained from chitin. It is biocompatible, biodegradable, and has antibacterial activity. In addition, chitosan reduces the levels of IL-1β, IL-6, and TNF-α, which also play a role in the pathogenesis of peri-implantitis, and exhibits anti-inflammatory effects on macrophages activated by lipopolysaccharide. Although many methods are used to treat peri-implantitis, successful and predictable results cannot be obtained. This study aims to examine the clinical and immunological findings and observe the changes in the non-surgical treatment of peri-implantitis using chitosan brush or titanium curette over 12 months. Sixty dental implants diagnosed with peri-implantitis clinically and radiographically at the Department of Periodontics, Faculty of Dentistry, Hacettepe University will be included in the study. Non-surgical peri-implantitis treatment of these patients will be performed using a chitosan brush (N=30, case group) or titanium curette (N=30, control group). Pre-operative and post-operative 3rd, 6th, and 12th months, clinical periodontal indices will be recorded, peri-implant crevicular fluid (PIF) will be collected, and maintenance treatment will be applied to the patients. IL-1β, TNF-α, IL-8, IL-10, and IL-17 levels in the collected PIF will be determined by the ELISA method. The effectiveness of chitosan brush and titanium curette in treating peri-implantitis will be evaluated and compared clinically and immunologically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chitosan Brush | Active Comparator | The implants in the chitosan brush group will be debrided with a chitosan brush dipped in sterile physiological saline solution using a rotary instrument system for 2 minutes. After mechanical treatment, the peri-implant pockets will be washed with sterile physiological saline solution. In cases with BOP+ and PD≥ 4 mm at 3 and 6 months after treatment, the treatment will be repeated in the same way as the previous one. Local infiltration anesthesia will be applied to the patients when deemed necessary. The prosthetic superstructures of the implants will not be removed for clinical examination or treatment. In cases where there is more than one implant in the same patient requiring peri-implantitis treatment, all of these implants will be included in the same treatment group. |
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| Titanium Curette | Active Comparator | The implants in the titanium curette group will be treated with titanium curettes for 2 minutes. After mechanical treatment, the peri-implant pockets will be washed with sterile physiological serum. In cases with BOP+ and PD≥ 4 mm at 3 and 6 months after treatment, the treatment will be repeated in the same way as the previous one. Local infiltration anesthesia will be applied to the patients when deemed necessary. The prosthetic superstructures of the implants will not be removed for clinical examination or treatment. In cases where there is more than one implant requiring peri-implantitis treatment in the same patient, all of these implants will be included in the same treatment group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-surgical periodontal treatment with chitosan brush | Procedure | Non-surgical treatment of pre-implantitis with chitosan brush |
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| Measure | Description | Time Frame |
|---|---|---|
| Probing Pocket Depth | The distance between the mucosal margin and the bottom of the peri-implant pocket [six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual) on each implant] | From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months) |
| Radiographic Bone Level (RBL) | RBL is determined in millimeters by metrically measuring the distance from the implant shoulder to the first bone-implant contact on the radiograph. Increasing RBL indicates worse outcome | From the baseline to the 12th month (Baseline, 6th, 12th months) |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival index (GI) | According to the GI system; 0: Normal gingiva
Six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual) on each implant. The gingival index of an implant is calculated by dividing the total score of that implant by 4. Increased GI indicates worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Buket Acar, PHD | Contact | +90 312 305 2217 | dtbuketacar@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University | Recruiting | Ankara | 06100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Non-surgical treatment of pre-implantitis with titanium curette | Device | Description: Non-surgical treatment of pre-implantitis with titanium curette |
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| From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months) |
| Plaque Index (PI) | According to PI scores; 0: No plaque
Six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual) were measured on each implant.The arithmetic average of 4 measurement values obtained from an implant is recorded as the PI score for that implant. Increased PI indicates worse outcome | From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months) |
| Bleeding on Probing | From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months) |
| Keratinized Mukoza Width | The distance between the keratinized mucosa margin and the mucogingival junction in the mid-buccal region of the implant | From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months) |
| Recession Depth | The distance between the margin of the prosthetic restoration and the keratinized mucosal marjin | From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months) |
| IL-1β | From PIOS | From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months) |
| TNF-α | From PIOS | From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months) |
| IL-8 | From PIOS | From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months) |
| IL-10 | From-PIOS | From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months) |
| IL-17 | From PIOS | From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months) |